Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries

B.P. Koirala Institute of Health Sciences

Status and phase: Unknown; Phase 4

Conditions: Lower Extremity Fracture

Treatments: Drug: Atropine; Drug: Glycopyrrolate; Drug: Normal Saline Flush, 0.9% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03580889

IRC/1087/017

Details and patient eligibility

About

A study to compare between intravenous atropine and glycopyrrolate in preventing spinal anesthesia induced hypotension in patients undergoing major lower limb orthopedic surgeries. Hypotension is the most common complication in spinal anesthesia that can be life threatening. If this can be prevented patients comfort can be increased and satisfaction as well.

Enrollment: 138 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA PS I and II,
• age 16 to 65,
• undergoing lower limb major orthopedic surgery,
• willing to participate

Exclusion criteria

• Contra indication to spinal anesthesia,
• patient refusal,
• ASA PS >III,
• cardiac diseases,
• hypertension >160/ 100,
• arrhythmias,
• Acute coronary syndrome,
• patients taking beta-blockers,
• hepatic and pulmonary diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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138 participants in 3 patient groups

Atropine sulphate

Active Comparator group

Description:

Atropine 5 mcg/kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blood pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly

Treatment:

Drug: Atropine

Glycopyrrolate

Active Comparator group

Description:

Glycopyrrolate 2.5 mcg / kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.

Treatment:

Drug: Glycopyrrolate

Normal Saline

Active Comparator group

Description:

Normal saline 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly.

Treatment:

Drug: Normal Saline Flush, 0.9% Injectable Solution